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GABAPENTIN MYLAN 300 MG HARD CAPSULES

Active substance(s): GABAPENTIN / GABAPENTIN / GABAPENTIN

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TOP LABEL

Gabapentin Mylan
#300 mg

Gabapentin Mylan
#300 mg

GLUE AREA

REVERSE

300
mg

Gabapentin Mylan
300 mg hard capsules
100 hard capsules

Each 300 mg hard capsule contains: 300 mg
of gabapentin. This product contains: lactose
monohydrate. Read the package leaflet before use.
For oral use. Take as directed by the doctor. Keep
out of the reach and sight of children. Do not
store above 25°C. Keep the container tightly closed.
PL 04569/0666 POM
1087525
[Site code]
Mylan, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.

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taking this medicine as they can be serious:
Common (may affect up to 1 in 10 people)
• serious chest infection which may cause fever,
chills, shortness of breath, cough, phlegm
and occasionally blood (pneumonia) • fits
(convulsions) • decreased white blood cell count
(leucopenia) which may cause you to suffer from
more frequent infections e.g. sore throat, fever,
severe chills and mouth ulcers etc.
Rare (may affect up to 1 in 1,000 people)
• loss of consciousness
Not known (frequency cannot be estimated
from the available data)
• anaphylaxis (serious, potentially life

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easily tell what medicine you have taken.
As this medicine may make you drowsy, it is
recommended that you ask someone else to
drive you to the doctor or hospital, or that you
call an ambulance. Signs of an overdose include
dizziness, double vision, slurred speech, loss of
consciousness, drowsiness and mild diarrhoea.
If you forget to take Gabapentin
If you forget to take a dose, take it as soon as you
remember unless it is time for your next dose.
Do not take a double dose to make up for a
forgotten capsule.
If you stop taking Gabapentin
Do not stop taking Gabapentin unless your

Gabapentin contains lactose
If you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicinal
product.
3. How to take Gabapentin
Always take this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Your doctor will determine what dose is
appropriate for you.
If you have the impression that the effect of
Gabapentin is too strong or too weak, talk to
your doctor or pharmacist.

Read the description of these signs in section
4 of this leaflet under ‘Stop taking this medicine
and contact your doctor immediately or go
to the nearest hospital casualty department
straight away if you experience any of the
following signs after taking this medicine as they
can be serious’
Other medicines and Gabapentin
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Medicines containing opioids such as
morphine
If you are taking any medicines containing

Common (may affect up to 1 in 10 people)
• urinary tract infection, general infections,
inflammation of the ear • loss of appetite or
an increased appetite. • anger towards others,
confusion, fluctuation in mood, depression,
anxiety, nervousness, difficulty with thinking.
• jerky movements, difficulty with speaking,
loss of memory, shaking, difficulty sleeping,
headache, numbness, tingling or pins and
needles, decreased sensation, difficulty with
coordination • rapid unusual eye movement,
increased, decreased or absent reflexes. • blurred
vision, double vision. • spinning sensation
(vertigo). • high blood pressure, flushing or

Antacids for indigestion
If gabapentin and antacids containing
aluminium and magnesium are taken at the
same time, absorption of gabapentin from
the stomach may be reduced. It is therefore
recommended that Gabapentin is taken at least
two hours after taking an antacid.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
Pregnancy
Gabapentin should not be taken during

kidney failure). • destruction of muscle fibres
associated with muscle cramps, muscle pain,
fever and red-brown discoloration of the urine
(rhabdomyolysis)
Gabapentin may cause a serious or lifethreatening allergic reaction that may affect
your skin or other parts of your body such as
your liver or blood cells. You may or may not
have rash when you get this type of reaction.
It may cause you to be hospitalized or to stop
Gabapentin.
Call your doctor right away if you have any of
the following symptoms:
• skin rash • hives • fever • swollen glands that do

threatening allergic reaction including difficulty
breathing, swelling of the lips, throat, and
tongue, and hypotension requiring emergency
treatment) • severe skin reactions that require
immediate attention such as swelling of the lips
and face, skin rash and redness (these may be
signs of a serious allergic reaction). • potentially
life-threatening skin rashes (Stevens-Johnson
syndrome) appearing initially as reddish targetlike spots or circular patches often with central
blisters on the trunk. Additional signs to look
for include ulcers in the mouth, throat, nose,
genitals and conjunctivitis (red and swollen
eyes). The rash may progress to widespread

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doctor tells you to. If your treatment is stopped
it should be done gradually over a minimum of
1 week. If you stop taking gabapentin suddenly
or before your doctor tells you, there is an
increased risk of seizures.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop taking this medicine and contact your
doctor immediately or go to the nearest
hospital casualty department straight away if
you experience any of the following signs after

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once in the morning, once in the afternoon and
once in the evening.
Use in children aged 6 years and above:
The dose to be given to your child will be
decided by your doctor as it is calculated against
your child’s weight. The treatment is started with
a low initial dose which is gradually increased
over a period of approximately 3 days.
The recommended dose to control epilepsy is
25-35 mg/kg/day. It is usually given in 3 divided
doses, by taking the capsule(s) each day, usually
once in the morning, once in the afternoon and
once in the evening.
Gabapentin is not recommended for use in

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children below 6 years of age.
Peripheral Neuropathic Pain:
Take the number of capsules as instructed by
your doctor. Your doctor will usually build up
your dose gradually.
The recommended starting dose will generally
be between 300 mg and 900 mg each day.
Thereafter, the dose may be increased stepwise
up to a maximum of 3600 mg each day and
your doctor will tell you to take this in 3 divided
doses, i.e. once in the morning, once in the
afternoon and once in the evening.
Older patients
If you are an elderly patient (over 65 years of

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Always swallow the capsules whole with plenty
of water. This medicine may be taken with or
without food.
Continue taking Gabapentin until your doctor
tells you to stop.
Epilepsy:
Use in adults and adolescents:
Take the number of capsules as instructed. Your
doctor will usually build up your dose gradually.
The starting dose will generally be between
300 mg and 900 mg each day. Thereafter,
the dose may be increased stepwise up to a
maximum of 3600 mg each day and your doctor
will tell you to take this in 3 divided doses, i.e.

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Uncommon (may affect up to 1 in 100 people)
• racing heartbeat • unusually reduced or slow
body movement • swelling that may involve the
trunk • increase in liver enzymes and bilirubin
seen in a blood test • fall • difficulty with thinking
• high blood sugar (most often seen in patients
with diabetes) • nettle rash or itchy rash
• agitation (a state of chronic restlessness and
unintentional and purposeless motions)
Rare (may affect up to 1 in 1,000 people)
• low blood sugar (most often seen in patients
with diabetes) • loss of consciousness

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could have serious consequences for you and
your baby.
Breast-feeding
Gabapentin, passes into human milk. Because
the effect on the nursing newborn is unknown,
it is not recommended to breast-feed your baby
while taking Gabapentin.
Driving and using machines
Gabapentin may cause dizziness, drowsiness
and tiredness. You should not drive, operate
machinery or engage in other potentially
hazardous activities until you know whether this
medication affects your ability to perform these
activities.

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pregnancy, unless you are told otherwise by
your doctor. Effective contraception must be
used by women of child-bearing potential.
There have been no studies specifically looking
at the use of gabapentin in pregnant women,
but other medications used to treat seizures
have reported an increased risk of harm to the
foetus, particularly when more than one seizure
medication is taken at the same time. Therefore,
whenever possible and only under the advice
of your doctor, you should try to take only one
seizure medication during pregnancy.
Do not suddenly stop taking this medicine as
this may lead to breakthrough seizure, which

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phosphokinase seen in a blood test • low levels
of sodium in the blood
Additional side effects in children
Aggressive behaviour was commonly reported.
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By
reporting side effects, you can help provide
more information on the safety of this medicine.

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opioids (such as morphine), please tell
your doctor or pharmacist as opioids may
increase the effect of gabapentin. In addition,
combination of gabapentin with opioids may
cause symptoms like sleepiness and/or decrease
in breathing.
Gabapentin is not expected to interact
with other antiepileptic medicines or oral
contraceptive pills containing norethindrone or
ethinyl estradiol.
Gabapentin may interfere with some laboratory
tests, if you require a urine test tell your doctor
or hospital that you are taking Gabapentin.

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the environment.
6. Contents of the pack and other
information
What Gabapentin contains
The active substance is gabapentin.
Each hard capsule contains either 100 mg,
300 mg or 400 mg gabapentin.
The other ingredients are:
Capsule contents: lactose anhydrous (see
section 2, ‘Gabapentin contains lactose’), maize
starch and talc.
Capsule shell: gelatin, sodium lauryl sulphate.
The 100mg capsules contain the colouring
titanium dioxide (E171); the 300mg capsules

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change to your condition.
If you experience any signs such as feeling dizzy
and drowsy (which could increase accidental
injury), confusion, loss of consciousness and
reduced mental state while taking gabapentin,
talk to you doctor or pharmacist for advice.
Important information about potentially
serious reactions
A small number of people taking gabapentin
get an allergic reaction or potentially serious
skin reaction, which may develop into more
serious problems if they are not treated. You
need to know the signs to look out for while you
are taking gabapentin.

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1000 capsules or in containers of 50, 100, 200 or
250 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.
Manufacturers
Gerard Laboratories, 35/36 Baldoyle Industrial
Estate, Grange Road, Dublin 13, Ireland.
Mylan Hungary Kft, H-2900 Komárom,
Mylan utca 1, Hungary
Generics [UK] Limited, Station Close, Potters Bar,
Hertfordshire, EN6 1TL, United Kingdom.
Date of revision January 2017

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you have a history of abuse or dependence.
During treatment
If you develop signs such as persistent stomach
pain, feeling sick and being sick contact your
doctor immediately as these may be signs of
acute pancreatitis (an inflamed pancreas).
A small number of people being treated with
anti-epileptics such as gabapentin have had
thoughts of harming or killing themselves. If at
any time you have these thoughts, contact your
doctor immediately.
Increase in seizures or new types of seizure have
been seen in some people taking gabapentin.
Talk to your doctor or pharmacist if you notice a

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blistering or peeling of the skin. • a severe
condition of the skin (Erythema multiforme)
that may affect the mouth and other parts of
the body signs include red, often itchy spots,
similar to the rash of measles, which starts on
the limbs and sometimes on the face and the
rest of the body. The spots may blister or may
progress to form raised, red, pale-centered
marks. Those affected may have fever, sore
throat, headache and/or diarrhoea. • an
inflamed pancreas which may cause stomach
pain (spreading to the back) and being sick. •
kidney disease leading to passing less urine than
usual, feeling or being sick, or confused (acute

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2. What you need to know before you take
Gabapentin
Do not take Gabapentin
• if you are allergic to gabapentin or any of the
other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Gabapentin:
• if you suffer from kidney problems
• if you are on haemodialysis (to remove waste
products because of kidney failure).
Cases of abuse and dependence have been
reported for gabapentin. Talk to your doctor if

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TBC

Gabapentin can also be used on its own to treat
adults and children over 12 years of age.
Peripheral neuropathic pain
Gabapentin is used to treat long lasting pain
caused by damage to the nerves. A variety
of different diseases can cause peripheral
(primarily occurring in the legs and/or arms)
neuropathic pain, such as diabetes or shingles.
Pain sensations may be described as hot,
burning, throbbing, shooting, stabbing, sharp,
cramping, aching, tingling, numbness, pins and
needles etc.

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not go away • swelling of your lip and tongue
• yellowing of your skin or of the whites of the
eyes • unusual bruising or bleeding • severe
fatigue or weakness • unexpected muscle pain •
frequent infections
These signs may be the first signs of a serious
reaction. A doctor should examine you to decide
if you should continue taking Gabapentin.
Other possible side effects:
Very common (may affect more than 1 in
10 people)
• viral infection. • feeling drowsy, dizziness, lack
of coordination. • feeling tired.

100 hard capsules
Each 300 mg hard capsule contains: 300 mg
of gabapentin. This product contains: lactose
monohydrate. Read the package leaflet before use.
For oral use. Take as directed by the doctor. Keep
out of the reach and sight of children. Do not
store above 25°C. Keep the container tightly closed.

What is in this leaflet
1. What Gabapentin is and what it is used for
2. What you need to know before you take
Gabapentin
3. How to take Gabapentin
4. Possible side effects
5. How to store Gabapentin
6. Contents of the pack and other information

1. What Gabapentin is and what it is used for
Gabapentin belongs to a group of medicines
used to treat epilepsy and peripheral
neuropathic pain.
Epilepsy
Gabapentin is used to treat various forms of
epilepsy (seizures that are initially limited to
certain parts of the brain, whether the seizure
spreads to other parts of the brain or not).
Your doctor will prescribe Gabapentin for you
to help treat your epilepsy when your current
treatment is not fully controlling your condition.
You should take Gabapentin in addition to
your current treatment unless told otherwise.

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dilation of blood vessels. • shortness of breath,
chest infection (bronchitis), sore throat and
discomfort when swallowing, cough, runny or
blocked nose. • vomiting (being sick), nausea
(feeling sick), problems with teeth, inflamed
gums, diarrhoea, stomach pain, indigestion,
constipation, dry mouth or throat, wind. • facial
swelling, bruises, acne. • joint pain, muscle
pain, back pain, twitching. • difficulty getting or
maintaining an erection. • swelling in the legs
and arms difficulty with walking, pain, generally
feeling unwell, flu-like symptoms. • increase
in weight. • accidental injuries, such as broken
bones, scratches or bruises.

Gabapentin Mylan
300 mg hard capsules

them, even if their signs of illness are the same
as yours.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

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Not known (frequency cannot be estimated
from the available data)
• sensing things that are not real (hallucinations)
• ringing in the ears • problems with abnormal
movements such as writhing, jerking
movements and stiffness affecting the eyes,
head, neck and body • hair loss • uncontrolled
passing of urine • increased breast tissue,
breast enlargement in males •problems with
sexual functioning including changes in sex
drive, inability to reach a sexual climax, delayed
ejaculation • signs of withdrawal (such as
anxiety, difficulty sleeping, feeling sick, pain,
sweating), chest pain • increase in creatine

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Package Leaflet: Information for the Patient
Gabapentin 100 mg Hard Capsules
Gabapentin 300 mg Hard Capsules
Gabapentin 400 mg Hard Capsules
(gabapentin)
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you
only. Do not pass it on to others. It may harm

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5. How to store Gabapentin
Keep this medicine out of sight and reach of
children.
Do not use this medicine after the expiry date,
which is stated on the label, carton or bottle after
‘EXP’. The expiry date refers to the last day of that
month.
Do not store above 25 °C.
HDPE bottle: Keep the bottle tightly closed.
PVC/Alu blister: Store in the original package.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help protect

300
mg

PL 04569/0666 POM
1087525
[Site code]
Mylan, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.

TBC

contain the colourings: titanium dioxide (E171)
and iron oxide yellow (E172) and the 400mg
capsules contain the colourings titanium dioxide
(E171), iron oxide yellow (E172) and iron oxide
red (E172).
What Gabapentin looks like and contents of
the pack
Each hard gelatin capsule contains a white
powder.
Capsule, hard body and cap: the 100 mg
capsules are white, the 300 mg capsules are
yellow and the 400 mg capsules are orange.
Gabapentin is available in blister packs of
10, 20, 30, 50, 60, 90, 100, 200, 250, 500 or

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PEEL HERE BUT DO NOT REMOVE

PEEL HERE BUT DO NOT REMOVE

FRONT FACE

age), you should take Gabapentin normally
except you have problems with your kidneys.
Patients with kidney problems or are receiving
haemodialysis
Your doctor may prescribe a different dosing
schedule and/or dose if you have problems with
your kidneys or are undergoing haemodialysis.
If you take more Gabapentin than you should
If you or someone else accidentally takes
too many capsules, or if you think a child has
swallowed any, contact your doctor or go to the
nearest hospital emergency unit immediately.
Take along any capsules that are left, the
container and the label so that the hospital can

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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